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- Tasks: Execute clinical studies and manage data in Clinical Trial Management Systems.
- Company: Nanosep AB is a leader in clinical research services, enhancing patient outcomes globally.
- Benefits: Enjoy flexible working options and gain valuable experience in the healthcare industry.
- Why this job: Join a dynamic team making a real impact on medical advancements and patient health.
- Qualifications: No specific experience required; enthusiasm and a willingness to learn are key!
- Other info: This is a contract role with opportunities for growth in clinical operations.
The predicted salary is between 30000 - 42000 ÂŁ per year.
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- Execute clinical studies/projects/activities and meet planned deliverables in line with agreed and defined roles and responsibilities.
- Support set-up and maintenance of information in Clinical Trial Management Systems (CTMS) and other systems as applicable, independent or under the responsibility of (Sr.) Clinical Project Manager (CPM) as applicable: Update data, timelines, milestones, Ethics Committee (EC) / Health Authority (HA) authorizations, etc. on an ongoing basis.
- Support (Sr.) CPM with study budget management, ensuring accurate planning, tracking and reporting of clinical study budget and Grant Plan as applicable. Perform Good receipt booking in line with Vendor financial report and study status, as required.
- Support set-up and maintenance of Trial Master File (TMF): Ensuring that all key documents are present and filed as appropriate in TMF, independent or under responsibility of (Sr.) CPM as applicable. Follow up with Clinical Trial Team at agreed frequency for TMF maintenance.
- Track clinical studies/projects/activities progress, ensure CTMS, TMF and other systems as applicable are up to date. Address questions; escalate issues or critical findings to project lead (Sr./CPM).
- Support in External Service Provider coordination:
- Support (Sr.) CPM in set up and coordination of External Service Providers, ensuring all information, documentation and material in place for clinical study/projects/activities at start, conduct and close-out. Follow-up with External Service Providers on day-to-day operations
- Ensure all data is reported to the Clinical Trial Team (CTT) and available to business colleagues
- Logistical support to study team (internal and external) onboarding process
- Support in meeting set up, coordination and meeting minutes, running reports from systems, draft project documentation.
- Support CTT in study start-up activities, recruitment and close-out activities as required.
- Champion the implementation of operational changes and transitions as required.
- Execute clinical studies/projects/activities and meet planned deliverables in line with agreed and defined roles and responsibilities.
- Support set-up and maintenance of information in Clinical Trial Management Systems (CTMS) and other systems as applicable, independent or under the responsibility of (Sr.) Clinical Project Manager (CPM) as applicable: Update data, timelines, milestones, Ethics Committee (EC) / Health Authority (HA) authorizations, etc. on an ongoing basis.
- Support (Sr.) CPM with study budget management, ensuring accurate planning, tracking and reporting of clinical study budget and Grant Plan as applicable. Perform Good receipt booking in line with Vendor financial report and study status, as required.
- Support set-up and maintenance of Trial Master File (TMF): Ensuring that all key documents are present and filed as appropriate in TMF, independent or under responsibility of (Sr.) CPM as applicable. Follow up with Clinical Trial Team at agreed frequency for TMF maintenance.
- Track clinical studies/projects/activities progress, ensure CTMS, TMF and other systems as applicable are up to date. Address questions; escalate issues or critical findings to project lead (Sr./CPM).
- Support in External Service Provider coordination:
- Support (Sr.) CPM in set up and coordination of External Service Providers, ensuring all information, documentation and material in place for clinical study/projects/activities at start, conduct and close-out. Follow-up with External Service Providers on day-to-day operations
- Ensure all data is reported to the Clinical Trial Team (CTT) and available to business colleagues
- Logistical support to study team (internal and external) onboarding process
- Support in meeting set up, coordination and meeting minutes, running reports from systems, draft project documentation.
- Support CTT in study start-up activities, recruitment and close-out activities as required.
- Champion the implementation of operational changes and transitions as required.
COS may additionally support below activities as deemed necessary by reporting manager or Head CPM:
- Responsible for developing monitoring plans and study specific tools as applicable
- Provide input to eCRF design & review, and other documents and systems, as applicable
- Responsible for central monitoring and data oversight on assigned clinical study(s) using available online data sources (eCRF, IRT, central lab, etc.) to ensure consistency, plausibility, completeness and correctness of the data
- Communicate any observations, deviations to protocol, safety alerts, quality issues, trend/patterns, risk factors etc. (that may affect the planned conduct of the study(s)) to the clinical team and CRAs for timely follow-up of actions and issue resolution
- Collaborate with Medical Lead to identify any safety trends, is a key team member of the Clinical Trial Team (CTT) and will lead the discussion in Data Review Team (DRT) meetings
- Prepare and share the Central Monitoring Package where applicable and agreed with the CRAs prior to monitoring visits
IQVIA is a leading global provider of clinical research services, commercial insights and healthcare intelligence to the life sciences and healthcare industries. We create intelligent connections to accelerate the development and commercialization of innovative medical treatments to help improve patient outcomes and population health worldwide . Learn more at level
-
Seniority level
Not Applicable
Employment type
-
Employment type
Contract
Job function
-
Job function
Research, Analyst, and Information Technology
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Clinical Operations Specialist employer: Nanosep AB
Contact Detail:
Nanosep AB Recruiting Team
StudySmarter Expert Advice 🤫
We think this is how you could land Clinical Operations Specialist
✨Tip Number 1
Familiarise yourself with Clinical Trial Management Systems (CTMS) and Trial Master Files (TMF). Understanding how these systems work will not only help you in the role but also show your potential employer that you're proactive and knowledgeable about the tools you'll be using.
✨Tip Number 2
Network with professionals in the clinical operations field. Attend industry events or join relevant online forums to connect with others who can provide insights or even refer you to opportunities at Nanosep AB.
✨Tip Number 3
Brush up on your project management skills, especially in budgeting and tracking. Being able to demonstrate your ability to manage study budgets effectively will make you a more attractive candidate for this role.
✨Tip Number 4
Prepare to discuss your experience with external service providers. Be ready to share examples of how you've coordinated with them in past roles, as this is a key aspect of the Clinical Operations Specialist position.
We think you need these skills to ace Clinical Operations Specialist
Some tips for your application 🫡
Understand the Role: Before applying, make sure to thoroughly read the job description for the Clinical Operations Specialist position at Nanosep AB. Understand the key responsibilities and required skills, as this will help you tailor your application.
Tailor Your CV: Customise your CV to highlight relevant experience in clinical operations, project management, and any specific systems mentioned, such as Clinical Trial Management Systems (CTMS) or Trial Master File (TMF). Use keywords from the job description to make your CV stand out.
Craft a Compelling Cover Letter: Write a cover letter that not only introduces yourself but also explains why you are a great fit for the role. Mention specific experiences that align with the responsibilities listed, such as budget management or coordination with external service providers.
Proofread Your Application: Before submitting, carefully proofread your CV and cover letter for any spelling or grammatical errors. A polished application reflects attention to detail, which is crucial in clinical operations.
How to prepare for a job interview at Nanosep AB
✨Understand the Role
Make sure you thoroughly read the job description and understand the key responsibilities of a Clinical Operations Specialist. Be prepared to discuss how your skills and experiences align with these tasks, such as managing clinical trial data and supporting project management.
✨Familiarise Yourself with CTMS and TMF
Since the role involves working with Clinical Trial Management Systems (CTMS) and Trial Master Files (TMF), it’s crucial to have a good grasp of these systems. Brush up on your knowledge about how they function and be ready to discuss any relevant experience you have in using them.
✨Showcase Your Budget Management Skills
The position requires support in study budget management. Prepare examples from your past experiences where you successfully managed budgets or tracked financials in projects. This will demonstrate your capability in this area.
✨Prepare for Team Collaboration Questions
As a Clinical Operations Specialist, you'll be part of a team that coordinates with various stakeholders. Think of examples that showcase your teamwork and communication skills, especially in situations where you had to resolve conflicts or ensure smooth collaboration.
